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PainChek Ltd ( (AU:PCK) ) has issued an announcement.
PainChek has secured an independent US legal opinion confirming its AI-driven PainChek device qualifies as an FDA-regulated medical device for Remote Therapeutic Monitoring reimbursement, enabling US healthcare professionals to use it when submitting claims to the Centers for Medicare & Medicaid Services. Building on its FDA De Novo classification and unique ability to assess pain in non-verbal dementia patients with musculoskeletal conditions, the company can now participate in the rapidly expanding RTM market, projected to be worth billions of dollars annually, and is adding an RTM reimbursement-based model to its existing SaaS offering to long-term care facilities. This dual-revenue approach, combined with long-dated US patent protection and partnerships covering more than 25,000 long-term care facilities and providers, materially strengthens PainChek’s growth prospects and competitive position in the US pain management and remote monitoring market.
The most recent analyst rating on (AU:PCK) stock is a Hold with a A$0.26 price target. To see the full list of analyst forecasts on PainChek Ltd stock, see the AU:PCK Stock Forecast page.
More about PainChek Ltd
PainChek Ltd is an Australian medical technology company that has developed an AI-powered pain assessment and monitoring application, positioned as the first FDA-cleared device able to assess pain in non-verbal dementia patients in long-term care settings. The company focuses on digitised pain detection and monitoring, with a core B2B SaaS model targeting long-term care facilities and a growing emphasis on the large US musculoskeletal monitoring market, supported by its patent protection in pain assessment through 2038.
Average Trading Volume: 172,366
Technical Sentiment Signal: Sell
Current Market Cap: A$56.43M
See more insights into PCK stock on TipRanks’ Stock Analysis page.

